[Federal Register: July 28, 1999 (Volume 64, Number 144)]
[Notices]               
[Page 40887-40888]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy99-83]                         


[[Page 40887]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0017]

 
International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Guidance on Validation of Analytical Procedures: Definition and 
Terminology; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a final 
guidance for industry entitled ``Validation of Analytical Procedures: 
Definition and Terminology.'' This guidance has been adapted for 
veterinary use by the International Cooperation on Harmonisation of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH) from an identically titled guidance adopted by the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH) and published in 
the Federal Register of March l, 1995 (60 FR 11260). The document 
provides guidance on characteristics that should be considered during 
the validation of analytical procedures included as part of 
registration applications for approval of veterinary medicinal products 
submitted to the European Union, Japan, and the United States.

DATES: Submit written comments at any time.

ADDRESSES: Copies of the final guidance document entitled ``Validation 
of Analytical Procedures: Definition and Terminology'' may be obtained 
on the Internet within the CVM home page at ``http://www.fda.gov/cvm/
fda/TOCs/guideline.html''. Persons without Internet access may submit 
written requests for single copies of the final guidance to the 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing your 
requests.
     Submit written comments on the final guidance document to the 
Policy and Regulations Team (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

     Regarding the guidance: William G. Marnane, Center for Veterinary 
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6966, e-mail ``wmarnane@cvm.fda.gov''.
     Regarding VICH: Sharon R. Thompson, Center for Veterinary Medicine 
(HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-594-1798, e-mail ``sthompso@cvm.fda.gov''.
SUPPLEMENTARY INFORMATION: In recent years, many important initiatives 
have been undertaken by regulatory authorities, industry associations, 
and individual sponsors to promote the international harmonization of 
regulatory requirements. FDA has participated in efforts to enhance 
harmonization and has expressed its commitment to seeking 
scientifically based harmonized technical procedures for the 
development of pharmaceutical products. One of the goals of 
harmonization is to identify and reduce the differences in technical 
requirements for drug development among regulatory agencies.
     FDA has actively participated in the ICH for several years to 
develop harmonized technical requirements for the approval of human 
pharmaceutical products among the European Union, Japan, and the United 
States. The VICH is a parallel initiative for veterinary pharmaceutical 
products. The VICH is concerned with developing harmonized technical 
requirements for the approval of veterinary pharmaceutical products in 
the European Union, Japan, and the United States, and includes input 
from both regulatory and industry representatives.
     The VICH meetings are held under the auspices of the Office 
International des Epizooties (OIE). During the initial phase of the 
VICH, an OIE representative chairs the VICH Steering Committee. The 
VICH Steering Committee is composed of member representatives from the 
European Commission, the European Medicines Evaluation Agency; the 
European Federation of Animal Health; the U.S. Food and Drug 
Administration; the U.S. Department of Agriculture; the Animal Health 
Institute; the Japanese Veterinary Pharmaceutical Association; and the 
Japanese Ministry of Agriculture, Forestry, and Fisheries.
     Four observers are eligible to participate in the VICH Steering 
Committee: One representative from the government of Australia/ New 
Zealand, one representative from the industry in Australia/ New 
Zealand, one representative from MERCOSUR (Argentina, Brazil, Uruguay, 
and Paraguay), and one representative from Federacion Latino-Americana 
de la Industria para la Salud Animal. The VICH Secretariat, which 
coordinates the preparation of documentation, is provided by the 
Confederation Mondiale de L'Industrie de la Sante Animale (COMISA). A 
COMISA representative also participates in the VICH Steering Committee 
meetings.
     In the Federal Register of January 27, 1998 (63 FR 3907), FDA 
published this guidance in draft form, giving interested persons until 
March 30, 1998, to submit comments. After consideration of comments 
received, a final draft guidance was submitted to the VICH steering 
committee.
     At a meeting held from October 20 through 22, 1998, the VICH 
Steering Committee endorsed the draft guidance entitled ``Validation of 
Analytical Procedures: Definition and Terminology.'' This guidance 
discusses the characteristics that should be considered during the 
validation of the analytical procedures included in an application for 
registration of veterinary medicinal products in the European Union, 
Japan, and the United States. It is not intended to cover testing 
requirements or procedures, rather it is to serve as a collection of 
terms and definitions. These common definitions such as ``analytical 
procedures,'' ``specificity,'' ``precision,'' ``accuracy,'' etc., are 
meant to bridge the differences that often exist among various 
compendia and requirements of the European Union, Japan, and the United 
States. The final guidance will be implemented in October of 1999.
     The final guidance represents the agency's current thinking on 
characteristics for consideration during the validation of the 
analytical procedures included as part of applications. It does not 
create or confer any rights for or on any person and will not operate 
to bind FDA or the public. An alternate approach may be used if it 
satisfies the requirements of applicable statutes, regulations, or 
both.
     As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
this guidance. The comments in the docket will be periodically 
reviewed, and, where appropriate, the guidance will be amended. The 
public will be notified of any such amendments through a notice in the 
Federal Register.


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    Dated: July 21, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19194 Filed 7-27-99; 8:45 am]
BILLING CODE 4160-01-F